Sino-US biopharma AnHeart Therapeutics and US precision oncology firm Guardant Health Inc. (NASDAQ: GH) have unveiled a partnership under which Guardant will provide companion diagnostics in support of AnHeart’s taletrectinib. This collaboration aims to enhance the development, regulatory approval, and commercialization of Guardant360 CDx and Guardant360 TissueNext assays in the United States and EU.
Partnership Details
Specifically, the two firms will collaborate on the development, regulatory approval, and commercialization of Guardant360 CDx (companion diagnostic) and Guardant360 TissueNext assays. These diagnostic tools are designed to support AnHeart’s taletrectinib, a ROS1 inhibitor being developed as a treatment for patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Taletrectinib Development
Taletrectinib received Breakthrough Therapy Designation (BTD) status from the US FDA in August 2022 and is currently the focus of both China-based and global Phase II trials (NCT04395677 and NCT04919811, respectively). This designation highlights the potential of taletrectinib to address significant unmet medical needs in the treatment of ROS1-positive NSCLC.
Guardant360 Diagnostic Tests
The Guardant360 CDx test is already FDA-approved to provide genomic profiling based on ctDNA in plasma to guide treatment in all solid tumors, including NSCLC. Guardant360 TissueNext is used to provide genomic profiling in relation to biopsy tissue samples. These diagnostic tools will play a crucial role in supporting the clinical development and commercialization of taletrectinib.-Fineline Info & Tech
